The Ministry of Environment, Forest and Climate Change, Government of India, has notified the Biological Diversity Rules, 2024 (Rules), defining the procedures to be followed while seeking approval or registering before the National Biodiversity Authority (NBA). The Rules will come into force effective from December 25, 2024 (from the expiry of 60 days from the date of notification in the Official Gazette).
The Rules provide for new forms and fees required to be complied with by the applicants, and introduce a few additional aspects that are essential to be kept in mind, such as:
The Rules provide for new forms and fees required to be complied with by the applicants, and introduce a few additional aspects that are essential to be kept in mind, such as:
- Provision carved out for regularizing past violations/non-compliances in view of possession of Indian biological resource prior to April 1, 2024;
- Additional obligations on foreign entities for accessing research results based on Indian biological resource;
- Inclusion of digital sequence information (DSI) of a biological resource within the purview of this Act when employed in an invention for obtaining intellectual property rights (IPR);
- Obligations on an entity for using foreign biological resources within the territory of India;
- Obligations on use of Indian biological resource for non-commercial research outside India; and
- Clarity on adjudication of penalties in case of non-compliance/contravention of provisions of the Act.
These Rules are issued in furtherance to the amendments made in August 2023 to the original Biological Diversity Act, 2002 (Act), namely, the Biological Diversity (Amendment) Act, 2023, which came into force from April 1, 2024.
Key Rules that impact Indian and foreign applicants for seeking approval or registering before the NBA are summarized in the document below.